ADA conference: Lantus safety vindicated by new trial

Sanofi's blockbuster insulin product Lantus (insulin glargine) does not increase the risk of serious cardiovascular and cancer side effects, according to new clinical trial data.

The results will be a relief for Sanofi after Lantus sales were hit by a 2009 study linking the pharma company's top-selling insulin product to serious cardiovascular and cancer side effects.

The new findings come from the Outcome Reduction with Initial Glargine Intervention (ORIGIN) study, which examined the use of daily Lantus injections in more than 12,500 people at high risk for, or in the early stages of, type 2 diabetes.

The long-term study saw patients given either Lantus or standard care (no insulin) for six years and found Sanofi's product neither increased nor reduced the risk of heart attacks, stroke, cancer or cardiovascular-related mortality.

Pierre Chancel (picture above), head of Sanofi's diabetes division, told PMLiVE: "It is now crystal clear that the use of Lantus is safe, it is super clean and safe on the cardio standpoint and the cancer question is closed. So there is no more question about the safety of Lantus."

The ORIGIN trial did confirm low rates of hypoglycaemia and some weight gain, both known side effects of insulin.

Sanofi will now hope it's new body of evidence will drawn a line under the 2009 publication in the German journal Diabetologia of four papers that suggested a possible link between insulin analogues, such as Lantus, and an increased risk of cancer.

Although acknowledging Diabetologia's actions had caused Sanofi some concern, Riccardo Perfetti, VP of medical affairs for the pharma company's diabetes division, told PMLiVE that the studies had been "dramatically flawed".

Nevertheless the publication of the studies had "some effect" on Lantus sales, Chancel confirmed. "The product continued to grow, but there was a change in trends," he said, adding that this took the form of a "slight slowing" of sales growth in 2009 through to the beginning of 2010.

Last year Lantus brought in sales of €3.92bn ($5.2bn) and it is the world's top-selling insulin product.

A preventative role for Lantus?The ORIGIN trial also saw some evidence that early use of Lantus in people at high risk of developing diabetes could prevent or slow the progression of the disease.

Investigators found that giving Lantus to patients with impaired fasting glucose or impaired glucose tolerance had a 28 per cent lower chance of developing type 2 diabetes over the trial's six year run, compared to those that didn't receive insulin. This effect was also seen to continue for a while after the injections were stopped.

Principal ORIGIN investigator Hertzel Gerstein from Ontario's McMaster University said: "We believe this is because giving insulin to those with somewhat elevated glucose levels allows the pancreas to rest during this period, essentially helping it to work longer."

But he acknowledged that the "durability" of the effect for more than three months after patients stopped taking insulin remains unknown.

Sanofi now plans to extend the study for a further two years, dubbing this stage ORIGINALE or Outcome Reduction with in an Initial Glargine intervention and Legacy Effect.

"All of these data will build on the extensive Lantus evidence in more than 47m real-life patient-years and over 10 years of clinical experience involving 80,000 participants in clinical development programmes," said Chancel.